(30 days)
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No
The summary explicitly states "Computer-assisted event marking and quantitative analysis" and "Computer-assisted reporting," but does not mention AI or ML, and the description of the device's function aligns with traditional signal processing and analysis rather than AI/ML techniques.
No
The device is used to acquire and review sleep recordings (polysomnography) and analyze signals, but it does not provide any therapy or treatment.
No
The "Intended Use / Indications for Use" states, "In no way are any of the functions represented as being in and of themselves diagnostic." It clarifies that the device acquires, reviews, and analyzes sleep recordings, but its output requires interpretation by trained professionals and does not make judgments of normality or provide diagnoses.
No
The description explicitly mentions a "XLTEK Connex Headbox," which is a hardware component used for acquiring signals. This indicates the device is not solely software.
Based on the provided information, the XLTEK Connex Headbox is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs analyze samples taken from the human body. The intended use describes the device as acquiring and reviewing physiological signals (EEG, respiratory, oximetry) directly from the patient. It does not mention analyzing biological samples like blood, urine, or tissue.
- The device's function is signal acquisition, review, and analysis. While it performs analysis, this analysis is of electrical and physiological signals, not the chemical or biological properties of a sample.
- The intended use explicitly states it's for sleep recordings (polysomnography). Polysomnography involves monitoring physiological parameters during sleep, which is distinct from analyzing biological samples.
Therefore, the XLTEK Connex Headbox falls under the category of a medical device used for physiological monitoring and analysis, not an IVD.
N/A
Intended Use / Indications for Use
The XLTEK Connex Headbox works in conjunction with Excel Tech Sleep software. This Connex headbox is used to acquire and review sleep recordings (polysomnography) in research or clinical environments for:
- Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional polygraphic recorders, signal transducers or amplifiers.
- Selection of recorded signal sections for on-screen review, annotation and marking of sleep stages.
- Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximetry signals.
- Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and frequency and simple statistical measures of marked events).
The Connex is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.
The Connex requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or trained medical professionals who will exercise professional judgment in using this information.
The Connex does not make any judgment of normality of the displayed signals or the result of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Product codes
OMB, OLV, OLZ, OLT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained polysomnographers or trained medical professionals / research or clinical environments
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
P
Excel-Tech Ltd. c/o Ms. Nicole Landreville, Eng. Regulatory Affairs Senior Manager 2568 Bristol Circle Oakville, Ontario Canada, L6H 5S1
Re: K042223
Trade/Device Name: XLTEK Connex Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMB. OLV. OLZ, OLT Dated (Date on orig SE ltr): August 16, 2004 Received (Date on orig SE ltr): August 17, 2004 APR - 9 2012
Dear Ms. Landreville:
This letter corrects our substantially equivalent letter of September 16, 2004.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/1/Picture/7 description: The image shows a signature on the left side and some text on the right side. The signature appears to be cursive and illegible. The text on the right side consists of the letters M, D, and O, with the letter D appearing twice. The text is aligned vertically.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ 1 of _1
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
K04223
Device Name: XLTEK Connex
Indications for Use:
The XLTEK Connex Headbox works in conjunction with Excel Tech Sleep software. This Connex headbox is used to acquire and review sleep recordings (polysomnography) in research or clinical environments for:
- Digital recording of high-level output signals (such as EEG, respiratory and oximetry . signals) from conventional polygraphic recorders, signal transducers or amplifiers.
- Selection of recorded signal sections for on-screen review, annotation and marking of . sleen stages.
- Computer-assisted event marking and quantitative analysis of EEG, respiratory and . oximetry signals.
- Computer-assisted reporting of simple measures obtained from the recorded signals (such . as magnitude, time and frequency and simple statistical measures of marked events)
The Connex is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.
The Connex requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or trained medical professionals who will exercise professional judgment in using this information.
The Connex does not make any judgment of normality of the displayed signals or the result of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Prescription Use X (Per 21 CFR 801.109) OR
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
(Optional Format 1-2-96)
510(k) Number_K0 42223